Bioanalytical Testing Services Market Report | Growth & Forecasts to 2030
[研究报告] 生物分析测试服务市场预计将从 2022 年的 46.4113 亿美元增长到 2030 年的 101.0882 亿美元;预计 2022 年至 2030 年的复合年增长率为 10.2%。
市场洞察和分析师观点:
生物分析测试是指定量评估血液、血浆、血清、尿液和唾液等生物体液或组织提取物中药物及其代谢物或生物标志物的浓度。这些测试服务由各种合同研究组织 (CRO) 提供,并被各种制药公司用于药物开发过程。制药公司越来越多地将研发活动外包,对生物仿制药和生物制剂的分析测试需求旺盛,推动了生物分析测试服务市场规模的扩大。
增长动力:
制药公司将不属于其内部结构核心的研发活动外包。将杂项活动外包使他们能够有效地专注于内部核心竞争力,从而使药物开发过程更好、更具成本效益。此外,将制造活动与研发一起外包,可以缩短周转期、增加专业知识并消除大量资本投资的需要,从而使他们受益。根据 BioPlan Associates 的《生物制药制造能力和生产调查》,分析测试/生物测定是 2022 年外包最多的服务,其次是毒性测试、验证服务、产品表征等。虽然发展中国家是通过合同制造对生物分析测试服务需求的最大贡献者,但美国仍然是一个潜在的外包目的地。调查中 39.6% 的非美国受访者更愿意将这些测试外包给美国的设施。在发展中国家中,中国和印度占生物技术和生物制药公司的很大一部分,这些公司更喜欢将生物分析测试外包给美国的设施。据报道,德国、英国、新加坡和日本是重要的外包目的地。因此,外包做法在世界范围内越来越受欢迎,特别是在发展中国家,从而有利于生物分析测试服务市场的增长。
制药企业正在广泛实施质量源于设计 (QbD) 概念。这进一步推动了制药公司采用外包服务,以提高其生产流程的稳健性。这也确保了最佳的产品质量和制造效率。QbD 得到了美国食品药品管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管机构的支持。多年来,随着 ICH Q9(质量风险管理)、ICH Q8(R2,药品开发)和 ICH Q10(药品质量体系)的发布,这一概念在制药行业获得了广泛关注。根据 ICH Q10 指南,分析方法对于药品质量体系至关重要。制造过程中的分析 QbD (AQbD) 实施可确保产品质量和性能。
外包生物分析测试服务可帮助制药企业降低业务风险,避免在分析设备和熟练专业人员方面进行大量投资,尤其是在产品处于开发初期时。在过去的几十年里,CRO 的出现极大地促进了生物分析测试服务市场的增长。全球有 1,000 多家 CRO 通过提供各种生物分析测试平台为制药公司提供支持。CRO 是高度专业化的基础设施,用于执行不同的药物发现过程,因此制药公司更愿意将研发业务外包给他们。
由于拥有具备快速提供优异结果的关键能力的专业分析测试服务提供商,制药公司越来越多地考虑将生物分析测试服务外包给第三方服务提供商,这推动了生物分析测试服务市场的增长。
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生物分析测试服务市场:
Bioanalytical Testing Services Market: Strategic Insights
Bioanalytical Testing Services Market
-
CAGR (2022 - 2030)
10.2%
-
Market Size 2022
US$ 4.64 Billion
-
Market Size 2030
US$ 10.11 Billion
Market Dynamics
GROWTH DRIVERS
- 制药公司研发活动外包增加
- 对生物仿制药和生物制剂的分析测试需求旺盛
FUTURE TRENDS
- 新兴疾病和罕见疾病药物研发活动不断增加
OPPORTUNITIES
- 制药行业持续增长
Key Players
- SGS SA
- Pharmaron Beijing Co Ltd
- Element Materials Technology Group Ltd
- CD BioSciences Inc
- Charles River Laboratories International Inc
- Eurofins Scientific SE
- Labcorp Drug Development Inc
- Syneos Health Inc
- KCAS Bioanalytical and Biomarker Services LLC
Regional Overview
- 北美(美国、加拿大、墨西哥)
- 欧洲(英国、德国、法国、俄罗斯、意大利、欧洲其他地区)
- 亚太地区(中国、印度、日本、澳大利亚、亚太地区其他地区)
- 南美洲和中美洲(巴西、阿根廷、南美洲和中美洲其他地区)
- 中东和非洲(南非、沙特阿拉伯、阿联酋、中东和非洲其他地区)
Market Segmentation
服务(药代动力学、生物标志物、免疫原性、病毒学测试、基于细胞的分析等)
疾病适应症(心血管疾病、神经系统疾病、代谢性疾病、自身免疫性疾病、呼吸系统疾病、肿瘤学、性健康、骨病等)
最终用户(制药和生物制药公司、合同研究组织
- CRO、合同开发和制造组织
地理(北美洲、欧洲、亚太地区、中东和非洲、南美洲和中美洲)
Bioanalytical Testing Services Market: Strategic Insights
-
CAGR (2022 - 2030)10.2% -
Market Size 2022
US$ 4.64 Billion -
Market Size 2030
US$ 10.11 Billion
Market Dynamics
- 制药公司研发活动外包增加
- 对生物仿制药和生物制剂的分析测试需求旺盛
- 新兴疾病和罕见疾病药物研发活动不断增加
- 制药行业持续增长
Key Players
- SGS SA
- Pharmaron Beijing Co Ltd
- Element Materials Technology Group Ltd
- CD BioSciences Inc
- Charles River Laboratories International Inc
- Eurofins Scientific SE
- Labcorp Drug Development Inc
- Syneos Health Inc
- KCAS Bioanalytical and Biomarker Services LLC
Regional Overview
- 北美(美国、加拿大、墨西哥)
- 欧洲(英国、德国、法国、俄罗斯、意大利、欧洲其他地区)
- 亚太地区(中国、印度、日本、澳大利亚、亚太地区其他地区)
- 南美洲和中美洲(巴西、阿根廷、南美洲和中美洲其他地区)
- 中东和非洲(南非、沙特阿拉伯、阿联酋、中东和非洲其他地区)
Market Segmentation
- CRO、合同开发和制造组织
复合年增长率(2022 - 2030 年)10.2%- 2022 年市场规模
46.4 亿美元 - 2030 年市场规模
101.1 亿美元
市场动态
- 制药公司研发活动外包增多
- 生物仿制药和生物制剂分析测试需求旺盛
- 新兴及罕见疾病药物研发活动不断增多
- 制药行业持续增长
关键人物;主力;重要一员
- 瑞士通用公证行
- 康龙化成北京有限公司
- 元素材料科技集团有限公司
- CD生物科学公司
- 查尔斯河实验室国际公司
- 欧陆科技
- Labcorp药物开发公司
- Syneos Health 公司
- KCAS 生物分析和生物标志物服务有限责任公司
区域概况
- 北美
- 欧洲
- 亚太
- 南美洲和中美洲
- 中东和非洲
市场细分
- 药代动力学
- 生物标志物
- 免疫原性
- 病毒学检测
- 基于细胞的检测
- 其他的
- 心血管
- 神经系统疾病
- 代谢紊乱
- 自身免疫性疾病
- 呼吸疾病
- 肿瘤学
- 性健康
- 骨病
- 其他的
- 制药和生物制药公司
- 合同研究组织
- 北美
- 欧洲
- 亚太地区
- 中东和非洲
- 南美洲和中美洲
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
报告细分和范围:
“全球生物分析测试服务市场”根据服务、疾病适应症和最终用户进行细分。根据服务,市场分为药代动力学、生物标志物、免疫原性、病毒学测试、基于细胞的检测等。就疾病适应症而言,生物分析测试服务市场分为心血管、神经系统疾病、代谢性疾病、自身免疫性疾病、呼吸系统疾病、肿瘤学、性健康、骨病等。根据最终用户,市场分为制药和生物制药公司、合同研究组织 (CRO)、合同开发和制造组织 (CDMO) 等。根据地理区域,生物分析测试服务市场分为北美(美国、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国、俄罗斯和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国和亚太地区其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋和中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷和南美洲和中美洲其他地区)
节段分析:
按服务划分,生物分析测试服务市场细分为药代动力学、生物标志物、免疫原性、病毒学测试、基于细胞的测定等。基于细胞的测定部分在 2022 年占据了最大的市场份额。预计在预测期内,该部分将录得最高的复合年增长率。对活细胞进行的所有测试都被视为基于细胞的测试。基于细胞的测定测量治疗药物、DNA、RNA、蛋白质、小分子和纳米颗粒的定量效果。这些测定基于疾病状态、增殖、细胞毒性、信号通路和基因表达。在监管环境中,基于细胞的测定通常用于确定药物产品或药物物质的生物活性(效力),并发现作用机制 (MOA)。另一方面,在免疫原性研究中,这些测定有助于确定患者体内产生的抗体的药物中和作用。
根据疾病指征,生物分析检测服务市场细分为心血管、神经系统疾病、代谢疾病、自身免疫性疾病、呼吸系统疾病、肿瘤学、性健康、骨病等。肿瘤学领域在 2022 年占据了最大的市场份额。此外,预计在预测期内,该领域的复合年增长率最高。在过去十年中,肿瘤学在止痛、化疗和其他疗法方面的进步极大地改变了癌症的诊断和治疗方法。卡铂和顺铂是用于治疗各种类型癌症的化疗药物。这些化合物含有铂,可以通过电感耦合等离子体质谱 (ICP-MS) 进行分析。该仪器分析铁、钠、铂、锂和钾等天然元素。将稀释的样品提取物引入氩等离子体炬进行雾化。然后,离子通过设置在质谱检测器四极杆过滤器上的透镜。这些方法根据最新的生物分析方法监管指南进行验证。
根据最终用户,生物分析测试服务市场细分为制药和生物制药公司、合同研究组织 (CRO)、合同开发和制造组织 (CDMO) 等。制药和生物制药公司部门在 2022 年占据了最大的市场份额。预计在预测期内,该部门的复合年增长率将达到最高。制药行业使用生物分析测试服务进行样品分析、毒代动力学 (TK)、生物标志物测定和剂量分析。这些公司采用这些服务来使其药品制造程序符合良好实验室规范 (GLP) 和良好临床规范 (GCP) 指南。生物分析测试服务旨在消除从开始到最终产品发布的药品生产过程中所涉及的风险。因此,生物分析测试服务在药物发现和开发中的关键性推动了制药和生物制药公司部门的生物分析测试服务市场的发展。
区域分析:
根据地域划分,全球生物分析测试服务市场分为五个主要区域:北美、欧洲、亚太、南美和中美以及中东和非洲。2022 年,北美在全球生物分析测试服务市场规模中所占份额最大。预计亚太地区在预测期内的复合年增长率最高。
美国在北美生物分析检测服务市场占有相当大的份额。该国生物分析检测服务市场的增长主要归因于政府在医疗保健方面的支出不断增加,以及对更有效治疗传染病的新型药物的需求激增。根据美国医疗保险和医疗补助服务中心的数据,2021 年该国全国医疗保健支出增长了 2.7%,达到 4.3 万亿美元,即每人 12,914 美元。卫生支出占全国 GDP 的 18.3%。根据美国卫生与公众服务部的数据,预计 2019 年至 2028 年期间全国卫生支出将以每年 5.4% 的速度增长,到 2028 年将达到 6.2 万亿美元。不断增长的医疗支出可能会增加对药物研发的资金分配,从而刺激对生物分析检测服务的需求。
根据 2020 年 7 月发布的《全球疾病负担》研究的新发现,美国非传染性神经系统疾病负担沉重且不断增加。根据约翰霍普金斯大学的数据,过去二十年,美国艾滋病毒感染、非典、莱姆病、登革热、西尼罗河病毒和寨卡病毒感染等疾病的病例迅速增加。此外,同一消息来源还证实,疟疾、结核病、霍乱、百日咳、流感、肺炎球菌病和淋病等重新出现的疾病的发病率激增。因此,各种感染和重新出现的疾病发病率的上升推动了公司在药物开发方面的努力,从而推动了美国生物分析测试服务市场的增长。
美国政府致力于为该国医药和保健产品的开发和商业化创造有利环境。该国拥有各种潜在的医药和医疗器械市场参与者,包括辉瑞、诺华、波士顿科学、Integra LifeSciences、安进和雅培,它们在医药和医疗器械行业的创新方面拥有各种专利。药物发现和开发程序必须符合良好实验室规范 (GLP) 和良好临床规范 (GCP),这需要在制造和试验阶段投入额外资源。因此,公司更愿意将这些业务外包。因此,各制药巨头增加药物开发活动,推动了美国生物分析测试服务市场的发展。
生物分析测试服务市场报告范围
报告属性 | 细节 |
---|---|
2022 年市场规模 | 46.4 亿美元 |
2030 年的市场规模 | 101.1亿美元 |
全球复合年增长率(2022 - 2030 年) | 10.2% |
历史数据 | 2020-2021 |
预测期 | 2023-2030 |
涵盖的领域 | 按服务
|
覆盖地区和国家 | 北美
|
市场领导者和主要公司简介 |
|
- 示例 PDF 通过定性和定量分析展示了内容结构和信息的性质。
行业发展和未来机遇:
以下列出了全球生物分析测试服务市场的主要参与者采取的各种举措:
- 2023 年 5 月,Labcorp 宣布计划通过扩建 CB Trial Laboratory(由 Labcorp Drug Development 和日本领先的临床实验室检测服务提供商 BML 共同管理的中央实验室)来增强其在日本的中央实验室影响力和药物开发能力。
- 2022 年 9 月,KCAS 生物分析和生物标志物服务公司 (KCAS) 完成了对位于法国里昂的 Active Biomarkers 的收购。Active Biomarkers 是一家著名的检测开发和专业生物分析实验室,在肿瘤学、传染病、炎症和神经退行性疾病方面拥有专业知识。此次收购增强了 KCAS 世界一流的生物分析专业知识,同时扩大了其大分子和细胞/基因治疗生物测定服务在欧洲的覆盖范围。
- 2022 年 7 月,Eurofins Scientific 宣布完成对 WESSLING 匈牙利的收购。WESSLING 匈牙利是匈牙利领先的环境、食品和生物制药产品测试实验室之一。WESSLING 在 2021 年创造了约 1500 万欧元的收入,员工人数约为 300 人。收购 WESSLING 匈牙利进一步扩大了 Eurofins 在中欧和东欧的业务,并巩固了其在生物制药产品测试领域的地位。
- 2022 年 7 月,SGS 宣布收购 Proderm。Proderm 是德国领先的化妆品、个人护理和医疗产品先进临床检测解决方案提供商。Proderm 为全球消费者护理和制药行业的客户提供服务,作为 CRO 开展从初步咨询到最终报告的临床研究。
- 2021 年 5 月,Labcorp 扩大了其在亚太地区的药物开发服务,为其新加坡客户提供了生物分析服务。
- 2023 年 3 月,康龙化成北京有限公司宣布其位于英国利物浦的基因治疗 CDMO 获得了英国政府生命科学创新制造基金 (LSMIF) 的一笔著名资助,用于扩建其病毒载体和 DNA 制造设施。
- 2022 年 9 月,KCAS 生物分析和生物标志物服务公司 (KCAS) 完成了对位于法国里昂的 Active Biomarkers 的收购。Active Biomarkers 是一家著名的检测开发和专业生物分析实验室,在肿瘤学、传染病、炎症和神经退行性疾病方面拥有专业知识。此次收购增强了 KCAS 世界一流的生物分析专业知识,同时扩大了其大分子和细胞/基因治疗生物测定服务在欧洲的覆盖范围。
竞争格局和重点公司:
SGS SA、Pharmaron Beijing Co Ltd、Element Materials Technology Group Ltd、CD BioSciences Inc、Charles River Laboratories International Inc、Eurofins Scientific SE、Labcorp Drug Development Inc、Syneos Health Inc、KCAS Bioanalytical and Biomarker Services LLC、ICON Plc 和 Intertek Group Plc 是生物分析测试服务市场的主要公司。这些公司专注于新技术、现有产品的改进和地域扩张,以满足全球日益增长的消费者需求。
Bioanalytical Testing Services Market Report Scope
Report Attribute | Details |
---|---|
Market size in | US$ 4.64 Billion |
Market Size by | US$ 10.11 Billion |
Global CAGR | 10.2% |
Historical Data | 2020-2021 |
Forecast period | 2023-2030 |
Segments Covered |
By 服务(药代动力学、生物标志物、免疫原性、病毒学测试、基于细胞的分析等)
|
Regions and Countries Covered |
北美(美国、加拿大、墨西哥)
|
Market leaders and key company profiles |
|
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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Frequently Asked Questions
The bioanalytical testing services market, by end user, is segmented into pharmaceutical and biopharmaceutical companies, contract research organizations (CRO), contract development and manufacturing organization (CDMO), and others. The pharmaceutical and biopharmaceutical companies segment held the largest market share in 2022, and the same segment is anticipated to register the highest CAGR during the forecast period.
The bioanalytical testing services market is expected to be valued at US$ 10,108.82 million in 2030.
The bioanalytical testing services market, by services, is segmented into pharmacokinetics, biomarkers, immunogenicity, virology testing, cell-based assays, and others. The cell-based assays segment held a larger market share in 2022. Also, the same segment is anticipated to register a higher CAGR during the forecast period.
The bioanalytical testing services market was valued at US$ 4,641.13 million in 2022.
The bioanalytical testing services market majorly consists of the players, including SGS SA, Pharmaron Beijing Co Ltd, Element Materials Technology Group Ltd, CD BioSciences Inc, Charles River Laboratories International Inc, Eurofins Scientific SE, Labcorp Drug Development Inc, Syneos Health Inc, KCAS Bioanalytical and Biomarker Services LLC, ICON Plc, and Intertek Group Plc.
Bioanalytical testing refers to quantitative assessment of a drug's and its metabolite's or biomarker's concentration in biological fluids such as blood, plasma, serum, urine, and saliva, or in tissue extracts. These testing services are provided by various contract research organizations (CROs) and adopted by various pharmaceutical companies in the drug development process.
Factors such as increasing outsourcing of R&D activities by pharmaceutical companies and high demand for analytical testing of biosimilars and biologics are propelling the market growth.
The List of Companies - Bioanalytical Testing Services Market
- SGS SA
- Pharmaron Beijing Co Ltd
- Element Materials Technology Group Ltd
- CD BioSciences Inc
- Charles River Laboratories International Inc.
- Eurofins Scientific SE
- Labcorp Drug Development Inc
- Syneos Health Inc
- KCAS Bioanalytical and Biomarker Services LLC
- ICON Plc
- Intertek Group Plc
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.